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NCT Number: NCT06390332

Centering Gender Affirming Resources in Higher Education

Centering gender Affirming Resources in higher Education (CARE) project is nested within the parent study "Reducing Alcohol Involved Sexual violence in higher Education" (RAISE; R01 AA023260; NCT05185440). CARE is a pilot cluster-randomized trial that centers trans and gender diverse (TGD) students who are at elevated risk for SV and hazardous drinking. CARE tests a novel college health and counseling center (CHC) training program designed to improve provider knowledge about TGD individuals, increase their self-efficacy and use of trans-inclusive practices. This includes an evaluation of the feasibility, acceptability, appropriateness, and usability of CARE's training intervention for college health and counseling center providers. This research will produce the first rigorously evaluated TGD-focused CHC provider training which has the potential to increase the accessibility of CHC's for TGD university students- ultimately lowering rates of alcohol use and SV among this disproportionately impacted population.

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Key information

Conditions

Sexual Violence Drinking Heavy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Elizabeth Miller, MD, PhD

CONTACT

About this study

"Centering gender Affirming Resources in higher Education (CARE)" expands upon RAISE's (R01 AA023260) cluster-randomized controlled trial across 28+ college campuses that is evaluating harm reduction interventions to reduce risk for sexual violence (SV) among undergraduate college students receiving care from college health and counseling centers (CHCs). A previous study by this research team found that students identifying as transgender or gender diverse (TGD) report particularly high lifetime prevalence of SV that is associated with greater odds of binge drinking compared to students not exposed to SV. Compounding these vulnerabilities, TGD students face high rates of discrimination on university campuses that drive heavy alcohol use and SV inequities, and lead to distrust of potential support resources like CHCs. CARE enhances RAISE's intervention by employing community-partnered methodologies to develop a training for CHC providers designed specifically to increase their competence in addressing TGD students' health needs with a focus on alcohol use and SV. The training involves a brief e-learning (asynchronous) intervention aimed at improving providers' knowledge and attitudes about TGD individuals, skills in delivering competent and affirming care, and knowledge of and self-efficacy to use TGD-inclusive practices. This trial will assess the feasibility, acceptability, appropriateness, and usability of CARE's training intervention in 15 randomized CHC sites from the parent study (Aim 1). The study will examine CHC provider knowledge and attitudes about TGD individuals, and their knowledge, self-efficacy, and use of TGD-inclusive practices with follow-up at 4-6 months (Aim 2).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who are seeing undergraduate students at health and counseling appointments as a provider.
  • Providers may include counselors, clinicians, nurses, health educators, medical assistants, social workers, advocates, and administrators.

Exclusion criteria

  • A college health or counseling center provider that does not interface with students.
  • A college health or counseling center provider not participating in the RAISE study.

Treatment and study plan

Giving Information for Trauma Support and Safety (GIFTSS) Training

Behavioral

Training for college health center staff and clinicians on GIFTSS intervention which is a universal education and brief counseling to address sexual violence prevention and intervention.

Centering gender Affirming Resources in higher Education (CARE) Learning Modules

Behavioral

Training for college health center clinicians and staff on trans and gender diverse (TGD) affirming clinical practices in addition to sexual violence and alcohol abuse prevention that is inclusive of TGD service users

Primary outcomes

  1. Provider perception of intervention feasibility

    Time frame: Immediately after CARE training completion

    Domain: Provider-Perceived Feasibility Specific Measurement: Feasibility of Intervention Measure (FIM). Specific Metric: End value Method of Aggregation: Mean score, range 1-5 cutoff mean score > 4, higher score indicates greater feasibility

  2. Provider perception of intervention acceptability

    Time frame: Immediately after CARE training completion

    Domain: Provider-Perceived Acceptability Specific Measurement: Acceptability of Intervention Measure (AIM) Specific Metric: End value Method of Aggregation: Mean score, range 1-5, cutoff mean score > 4, higher score indicates greater acceptability

  3. Provider perception of intervention appropriateness

    Time frame: Immediately after CARE training completion

    Domain: Provider-Perceived Appropriateness Specific Measurement: Intervention Appropriateness Measure (IAM) Specific Metric: End value Method of Aggregation: Mean score, range 1-5 , cutoff mean score > 4, higher score indicates greater appropriateness

  4. Provider perception of intervention usability

    Time frame: Immediately after CARE training completion

    Domain: Provider-Perceived Usability Specific Measurement: System Usability Scale (SUS) Specific Metric: End value Method of Aggregation: Mean score, range 1-5 , cutoff mean score > 4, higher score indicates greater usability

Secondary outcomes

  1. Knowledge and attitudes about TGD individuals.

    Time frame: Baseline- Before taking CARE training

    Domain: Assessing provider knowledge, attitudes, and beliefs about transgender people Specific Measurement: Transgender Knowledge, Attitudes, and Beliefs (T-KAB) scale Specific Metric: End value Method of Aggregation: Mean score, range 1 to 4, 4 indicating favorable attitudes and beliefs towards transgender people

  2. Knowledge and attitudes about TGD individuals.

    Time frame: At 6 months

    Domain: Assessing provider knowledge, attitudes, and beliefs about transgender people Specific Measurement: Transgender Knowledge, Attitudes, and Beliefs (T-KAB) scale Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 4, 4 indicating favorable attitudes and beliefs towards transgender people

  3. Attitudes concerning transphobia

    Time frame: Baseline- Before taking CARE training

    Domain: Assessing provider's attitudes regarding transphobia Specific Measurement: Transphobia Scale Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating a lesser degree of transphobia

  4. Attitudes concerning transphobia

    Time frame: At 6 months

    Domain: Assessing provider's attitudes regarding transphobia Specific Measurement: Transphobia Scale Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating a lesser degree of transphobia

  5. Human value of transgender people

    Time frame: Baseline- Before taking CARE training

    Domain: Assessing how providers view the human value of transgender people Specific Measurement: Transgender Attitudes and Beliefs Scale (TABS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating trans and gender diverse people hold high human value

  6. Human value of transgender people

    Time frame: At 6 months

    Domain: Assessing how providers view the human value of transgender people Specific Measurement: Transgender Attitudes and Beliefs Scale (TABS) Specific Metric: Change from Baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating trans and gender diverse people hold high human value

  7. Use of TGD-inclusive practices

    Time frame: Baseline- Before taking CARE training

    Domain: Use of transgender and gender diverse-inclusive practices Specific Measurement: The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating high preparedness and knowledge to work with transgender patients

  8. Use of TGD-inclusive practices

    Time frame: At 6 months

    Domain: Use of transgender and gender diverse-inclusive practices Specific Measurement: The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS) Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating high preparedness and knowledge to work with transgender patients

  9. Trans-Inclusivity in professional settings

    Time frame: Baseline- Before taking CARE training

    Domain: Assessing how trans-inclusive providers are in their practice Specific Measurement: The Trans-Inclusive Provider Scale (TIPS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 5, 5 indicating high trans-inclusivity in care practices)

  10. Trans-Inclusivity in professional settings

    Time frame: At 6 months

    Domain: Assessing how trans-inclusive providers are in their practice Specific Measurement: The Trans-Inclusive Provider Scale (TIPS) Specific Metric: Change from Baseline Method of Aggregation: Mean score, range 1 to 5, 5 indicating high trans-inclusivity in care practices

  11. Social desirability

    Time frame: Baseline- Before taking CARE training

    Domain: Measure of social desirability Specific Measurement: Marlowe- Crowne Social Desirability Scale Specific Metric: End Value Method of Aggregation: True and false questions, summary score from 0 to 1

  12. Social desirability

    Time frame: At 6 months

    Domain: Measure of social desirability Specific Measurement: Marlowe- Crowne Social Desirability Scale Specific Metric: Change from Baseline Method of Aggregation: True and false questions, summary score from 0 to 1

  13. Self-Efficacy to use trans and gender affirming practices

    Time frame: Baseline- Before taking CARE training

    Domain: Self-efficacy to use trans and gender affirming practices Specific Measurement: Investigator Developed Specific Metric: End value Method of Aggregation: Mean score, range 1 to 5, 5 indicating greater self-efficacy to use trans-affirming practices

  14. Self-Efficacy to use trans and gender affirming practices

    Time frame: At 6 months

    Domain: Self-efficacy to use trans and gender affirming practices Specific Measurement: Investigator Developed Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 5, 5 indicating greater self-efficacy to use trans-affirming practices

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Gartner, PhD

CONTACT

[email protected]

412-624-7232

Regina Futcher, MSW

CONTACT

[email protected]

757-272-3783

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Opportunity Fund

Registry information

Official study title

Inclusive Practices for Gender Minority College Students to Reduce Sexual Violence and Heavy Drinking

Acronym: CARE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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